FDA 510(k) Application Details - K143051

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K143051
Device Name Abutment, Implant, Dental, Endosseous
Applicant THE ARGEN CORPORATION
5855 OBERLIN DRIVE
SAN DIEGO, CA 92121 US
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Contact Maria Rao
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 10/23/2014
Decision Date 09/16/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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